BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUVEIN HF470

    MDR report key: 6185509 · Received December 14, 2016

    Report

    Report Number
    MW5066759
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    December 12, 2016
    Report Date
    December 14, 2016
    Manufacturer
    ACCUVEIN INC.
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BASE FROM THE FLEX ARM FOR THE ACCUVEIN HOLDER BROKE OFF. NURSE WAS POSITIONING THE ACCUVEIN AND THE BASE FOR THE HOLDER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823721 ACCUVEIN HF470 ACCUVEIN HF470 KZA ACCUVEIN INC. HF470

    Patients

    Seq Age Sex Outcome Treatment
    1